Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)

Asthma Clinical Trial

— REVEAL  

Official title:

PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04550962
• Other study ID #: OBS16688
• Status: Active, not recruiting
• Start date: November 2, 2020
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary Objective:

The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide [FeNO]), and concomitant treatments for asthma.

Secondary Objectives:

The secondary objectives of the study are:

• To characterize real-world use patterns of DUPIXENT for asthma (eg, most commonly used regimens, reason for initiation of new asthma treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching)

• To assess the effectiveness of DUPIXENT in asthma patients in a real world setting (lung function improvement, exacerbation rate, asthma control)

• To assess comorbid type 2 conditions (atopic/allergic) and patterns of use and effects of treatment in comorbid conditions in asthma patients treated with Dupixent

• To collect data on HealthCare Resource Utilization (HCRU)

• To collect safety data on study participants in the real-world setting.

Description:

Each patient will be followed during 36 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 375
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

• Male or female, 12 years or older Initiating treatment with Dupixent for asthma according to the country-specific prescribing information Willing and able to comply with the required clinic visits, study procedures and assessments.

Provided signed informed consent

• Most important exclusion criteria for potential participants Patients who have a contraindication to Dupixent according to the country-specific prescribing information Treatment with Dupixent within 6 months before the baseline visit. Note: for patients who have been treated previously with DUPIXENT a washout period of 6 months is required before Visit 1.

Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments Patients currently participating in any interventional clinical trial which modifies patient care.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Dupilumab SAR231893
Pharmaceutical form:solution Route of administration: subcutaneous Dose regimen:

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320001	Ciudad Autonoma Bs As
Argentina	Investigational Site Number : 0320008	Ciudad Autonoma Buenos Aires
Argentina	Investigational Site Number : 0320005	La Plata	Buenos Aires
Argentina	Investigational Site Number : 0320009	San Miguel de Tucuman
Argentina	Investigational Site Number : 0320004	Santa Fe
Argentina	Investigational Site Number : 0320006	Villa Rosa	Buenos Aires
Chile	Investigational Site Number : 1520002	Quillota	Valparaíso
Chile	Investigational Site Number : 1520001	Santiago	Reg Metropolitana De Santiago
Colombia	Investigational Site Number : 1700009	Barranquilla
Colombia	Investigational Site Number : 1700004	Bogota
Colombia	Investigational Site Number : 1700003	Bucaramanga
Israel	Investigational Site Number : 3760008	Ashdod
Israel	Investigational Site Number : 3760004	Ashkelon
Israel	Investigational Site Number : 3760003	Jerusalem
Israel	Investigational Site Number : 3760005	Jerusalem
Israel	Investigational Site Number : 3760001	Kfar Saba
Israel	Investigational Site Number : 3760006	Rehovot
Israel	Investigational Site Number : 3760007	Tel Aviv
Kuwait	Investigational Site Number : 4140001	Kuwait
Lebanon	Investigational Site Number : 4220003	Achrafieh
Lebanon	Investigational Site Number : 4220001	Beirut
Lebanon	Investigational Site Number : 4220002	Beirut
Mexico	Investigational Site Number : 4840003	Durango
Qatar	Investigational Site Number : 6340001	Doha
Russian Federation	Investigational Site Number : 6430005	Chelyabinsk
Russian Federation	Investigational Site Number : 6430004	Moscow
Russian Federation	Investigational Site Number : 6430007	Moscow
Russian Federation	Investigational Site Number : 6430006	Rostov-on-Don
Russian Federation	Investigational Site Number : 6430008	Saratov
Russian Federation	Investigational Site Number : 6430002	Stavropol
Saudi Arabia	Investigational Site Number : 6820005	Jeddah
Saudi Arabia	Investigational Site Number : 6820004	Makkah
Saudi Arabia	Investigational Site Number : 6820001	Riyadh
Saudi Arabia	Investigational Site Number : 6820002	Riyadh
Singapore	Investigational Site Number : 7020001	Singapore
Singapore	Investigational Site Number : 7020002	Singapore
United Arab Emirates	Investigational Site Number : 7840006	Abu Dhabi
United Arab Emirates	Investigational Site Number : 7840001	Dubai
United Arab Emirates	Investigational Site Number : 7840007	Dubai
United Arab Emirates	Investigational Site Number : 7840002	Sharjah
United Arab Emirates	Investigational Site Number : 7840004	Sharjah

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Israel,  Kuwait,  Lebanon,  Mexico,  Qatar,  Russian Federation,  Saudi Arabia,  Singapore,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Characteristics: Socio-demographics		At baseline
Primary	Baseline Characteristics: Medical history	Including asthma history and asthma treatment history.	At baseline
Primary	Baseline Characteristics: Disease characteristics		At baseline
Primary	Baseline Characteristics: Concomitant treatments for asthma		At baseline
Secondary	Dupixent and other asthma treatment use patterns	Including doses and dose frequency, treatment duration, asthma treatment associations (eg, Dupixent monotherapy, Dupixent + inhaled corticosteroids (ICS), Dupixent + ICS + additional controllers, oral corticosteroid (OCS) burst), and reasons for initiation and for discontinuation/switching.	Baseline to Month 54
Secondary	Lung function	Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time.	Baseline to Month 54
Secondary	Annualized exacerbation rate	An Exacerbation event is defined as a deterioration of asthma requiring: Use of systemic corticosteroids for =3 days; or; Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	Baseline to Month 54
Secondary	Patient reported outcomes	For asthma and type 2 comorbidities over time.	Baseline to Month 54
Secondary	Healthcare Resource Utilization	The Healthcare Resource Utilization (HCRU) is a questionnaire filled out by the participating site at baseline and at clinical visits (scheduled and unscheduled) throughout the study.	Baseline to Month 54
Secondary	Number of participants with adverse events (AE) and serious adverse events (SAE)		Baseline to Month 54